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Sarah Shen's fever-alert patch had a working prototype and a standing ovation. Then one question about software classification revealed the foundations were missing, and rebuilds cost three to five times more.
A test lab is quiet, well-lit and interruption-free. Real hospitals aren't. IDE's Minimum Viable Chaos method deliberately breaks that illusion, testing devices under real clinical noise, before regulators or patients do.
Kent DiasAbeygunawardena on why regulatory clearance gets you into market, but clinician adoption is what decides commercial success, and how Human Factors Engineering (HFE) is now shaping devices from day one, not validating them at the end.




